FDA Says Spiriva Trial Results Show No Increased Risk

摘要

The FDA expects a complete report in November from Boehringer Ingelheim on the study Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT). The study helps counter safety concerns highlighted in recently published meta-analyses of Spiriva data. "Results from this trial will ... help to address some issues raised about tiotropium in the two recent publications," the FDA says in a MedWatch alert issued last week. According to the alert, preliminary results from UPLIFT show "no increased risk of stroke with tiotropium bromide compared to placebo" in patients with chronic obstructive pulmonary disease (COPD). This news is positive for the product because a MedWatch alert in March notified healthcare professionals of a possible increased risk of stroke in patients taking the product.